No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
AstraZeneca · Industry
Who this trial is looking for
This trial is looking for adults with a specific type of kidney disease who can receive a new treatment called AZD1613. Participants will either receive the treatment through an injection under the skin or directly into the bloodstream and will be monitored for safety and how the body processes the drug.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with autosomal dominant polycystic kidney disease.
My kidney function is between 45 and 90 mL/min.
I weigh at least 45 kg.
My body mass index is between 18 and 35.
I am a female without the ability to have children.
You may not be able to join if
I have heart or serious blood vessel problems.
I test positive for hepatitis or HIV.
I have a history of serious heart rhythm issues.
I have low hemoglobin or other significant blood problems.
My blood pressure is higher than 160/100 mmHg.
I have had kidney cyst treatments in the last 12 weeks.
I have any major issues shown in my heart tests.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
A study to investigate safety, tolerability, and pharmacokinetics of AZD1613 following subcutaneous or intravenous administration in participants with autosomal dominant polycystic kidney disease (ADPKD).
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Patients with ADPKD Mayo Class (IB-IE), as per clinical diagnosis (MIC) assessed centrally. Genetic testing results will not be used for eligibility purposes
* eGFR = 45 to 90 mL/min /1.73m2
* Body weight ≥ 45 kg and body mass index within the range 18 to 35 kg/m2 (inclusive).…
Inclusion Criteria:
* Patients with ADPKD Mayo Class (IB-IE), as per clinical diagnosis (MIC) assessed centrally. Genetic testing results will not be used for eligibility purposes
* eGFR = 45 to 90 mL/min /1.73m2
* Body weight ≥ 45 kg and body mass index within the range 18 to 35 kg/m2 (inclusive).
* Females are to be of non-childbearing potential
Exclusion Criteria:
* As judged by the investigator, any evidence of cardiac, vascular, and other renal conditions which in the investigator's opinion makes it undesirable for the participant to participate in the study.
* Positive hepatitis C antibody, hepatitis B virus surface antigen, or human immunodeficiency virus test, at screening.
* History of QT prolongation associated with other medications that required discontinuation of that medication.
* Congenital long QT syndrome.
* History of ventricular arrhythmia requiring treatment. Patients with atrial fibrillation/flutter and controlled ventricular rate HR \< 100 bpm can be eligible as judged by the investigator.
* Haemoglobin below the lower limit of the normal range or any other clinically significant haematological abnormality as judged by the investigator.
* Any clinically important abnormalities in clinical chemistry, haematology, coagulation, or urinalysis results other than those specifically described as exclusion criteria herein, as judged by the investigator.
* Systolic BP \> 160 mmHg or diastolic BP \> 100mmHg or HR \< 50 bpm or \> 100 bpm at screening. Patients taking anti-hypertensive medication should be on a stable treatment regimen of antihypertensive therapy for at least 30 days prior to the screening visit.
* Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG and any abnormalities in the 12-lead ECG that, as considered by the investigator, may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology or left ventricular hypertrophy.
* Kidney cyst interventions such as cyst aspiration or cyst fenestration within 12 weeks prior to screening and during the screening period, or such interventions planned or anticipated within the follow-up period.
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